RecruitingNot ApplicableNCT07194551

Assessing Uterine Cancer Risk in Lynch Syndrome Carriers Using Vaginal Self-sampling and a Health Questionnaire

Lynch Syndrome Carriers' Uterine Cancer Health Assessment: Sampling and DNA-based Detection

Sponsor

University of British Columbia

Enrollment

30 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Lynch Syndrome

Summary

The goal of this study is to find out if self-collected vaginal swabs can be used to detect early signs of uterine cancer or related conditions in people with Lynch syndrome (LS) who still have their uterus. The study also tests if people with LS are willing and able to collect these samples themselves and whether they find the process acceptable. The main questions this study asks are: * Will people with LS take part in self-collection of vaginal samples, and do they find it acceptable? * Can vaginal DNA mutations predict cancer risk or match results from other genetic or biopsy testing? * Can a cancer risk model used in the general population also help identify risk in people with LS? Participants will: * Answer a health questionnaire about lifestyle and symptoms * Collect their own vaginal swabs and measure their vaginal pH at home using a self-collection kit * Complete short surveys around the time of self-collection and at the end of the study

Eligibility

Sex: FEMALEMin Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a simple vaginal self-swab test (done at home) combined with a health questionnaire can detect early signs of uterine (endometrial) cancer in women who carry Lynch syndrome — a genetic condition that significantly increases the risk of uterine and other cancers. **You may be eligible if...** - You have been diagnosed with Lynch syndrome confirmed by genetic testing - You have an intact uterus (no hysterectomy) - You are 30 years of age or older **You may NOT be eligible if...** - You have a personal history of endometrial (uterine) cancer or endometrial hyperplasia (precancerous thickening of the uterine lining) - You have had pelvic radiation or an endometrial ablation procedure - You are currently pregnant or become pregnant during the study Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTVaginal DNA swab, microbiome swab and pH test

Participants will receive up to three at-home collection kits with a vaginal swab for DNA collection, a vaginal swab for microbiome sampling, a vaginal pH testing kit, and instructions on how to perform the sample collection. Vaginal DNA will be collected using Zymo DNA/RNA Shield, vaginal microbiome DNA will be collected using Genotek OMNIgene, and vaginal pH will be collected using GYNEX pHem-Alert. Those with abnormal findings will be referred to a gynecologist or gynecologic oncologist for appropriate clinical assessment. Those with negative pathology will remain in the study. The self-collection will be repeated up to two more times, at eight-to-nine-month intervals, up to three successful self-collections.